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U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®

* OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by theFDA * Regulatory approval for interchangeability was supported by positive phase III data demonstrating comparable efficacy and safety profile with the reference product XOLAIR® (omalizumab)[1] * The ava...

2025-03-10 07:16 3789

GenAssist Ltd Announces FDA Clearance of Investigational New Drug Application for GEN6050X, a Globally First-in-Class Base Editing Drug for Duchenne Muscular Dystrophy

SUZHOU, China, March 6, 2025 /PRNewswire/ -- On March 06, 2025, GenAssist Ltd (GenAssist), a pioneering gene-editing biotechnology company specializing in genome medicines, is thrilled to announce that it has receivedclearance from the U.S Food and Drug Administration(FDA) for its Investigational...

2025-03-06 17:00 2400

Akeso Announces Completion of Patient Enrollment in The Phase III Clinical Trial of Cadonilimab for Adjuvant Treatment of High-Risk Recurrent Hepatocellular Carcinoma

HONG KONG, March 5, 2025 /PRNewswire/ -- Akeso, Inc. (9926. HK) ("Akeso" or the "Company") is pleased to announce the completion of patient enrollment for its Phase III registrational clinical trial (COMPASSION-22/AK104-306) evaluating cadonilimab, the world's first PD-1/CTLA-4 bispecific antibod...

2025-03-06 08:30 2899

CStone Submits Clinical Trial Application in Australia for CS5001 (ROR1 ADC) in Combination with First-Line Standard-of-Care for DLBCL

* Phase Ib trial to evaluate CS5001 in combination with R-CHOP as a first-line treatment for diffuse large B-cell lymphoma (DLBCL), aiming to reshape the standard-of-care landscape. * CS5001 is also being investigated globally in a multi-center Phase Ib clinical trial for multiple solid tumor...

2025-03-06 08:10 3140

SECuRE trial update: 92% of pre-chemo participants experience greater than 35% drop in PSA levels across all cohorts. Cohort Expansion Phase commences.

HIGHLIGHTS * Safety Review Committee (SRC) meeting confirms end of the Dose Escalation Phase and commencement of the Cohort Expansion Phase (Phase II stage) of the SECuRE study. * Based on the efficacy and safety assessment of all cohorts and the focus on earlier stages of treatment, the SRC...

2025-03-05 21:44 3567

SanyouBio Launches 73 Whole-Series Bispecific Reference Antibody Products, Facilitating New Breakthroughs in Bispecific Drug Development

SHANGHAI, March 5, 2025 /PRNewswire/ -- SanyouBio announced today the official launch of 73 whole-series bispecific antibody reference products, covering globally approved and representative clinical-stage bispecific antibody drugs. The launch of this product series will provide robust support fo...

2025-03-05 20:00 2568

XPOVIO® (selinexor) Approved for Commercialization in Indonesia, Further Expanding Antengene's Commercial Presence in APAC

- XPOVIO® is the first and only approved XPO1 inhibitor in Indonesia. - From the second half of 2024 to now, XPOVIO® was successively approved in Thailand, Malaysia and Indonesia, significantly expanding Antengene's commercial presence in APAC. To date, XPOVIO® has been approved for multiple ind...

2025-03-05 13:00 2874

Celltrion receives U.S. FDA approval for STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) biosimilars referencing PROLIA® and XGEVA®

* STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of reference products PROLIA® (denosumab) and XGEVA® (denosumab) respectively[1], [2] * The FDA approval is based on robust clinical evidence, which show no clinically meaningful differences fr...

2025-03-04 12:28 3115

Raziel and Fosun Pharma (by JuveStar an affiliate company of Fosun Pharma) Initiate Phase 3 Registration Trial in China for Submental Fat Reduction ("double chin")

REROVOT, Israel, March 3, 2025 /PRNewswire/ -- Raziel Therapeutics, a pharmaceutical company developing next-generation novel prescription products for the medical aesthetics market, announces phase 3 study initiation inChina for the treatment of fat reduction in the submental area. Submental fat...

2025-03-04 09:00 2469

CStone Announces First Patient Dosed in Global Multicenter Phase I Clinical Trial of CS2009, a PD-1/VEGF/CTLA-4 Trispecific Antibody

SUZHOU, China, March 3, 2025 /PRNewswire/ --CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced thatthe first patient has been successfully dosed in the global multicenter P...

2025-03-04 08:10 4201

METiS Pharmaceuticals Appoints Mark Herbert as Chief Business Officer

HANGZHOU, China, March 3, 2025 /PRNewswire/ -- METiS Pharmaceuticals, a clinical-stage, AI-driven biotechnology company specializing in innovative drug delivery technologies, today announced the appointment ofMark Herbert as Chief Business Officer (CBO), effectiveJanuary 22, 2025. In this role, M...

2025-03-03 16:20 2822

METiS Pharmaceuticals Appoints Mark Herbert as Chief Business Officer

CARsgen's Claudin18.2 CAR-T Therapy Satri-cel Granted Breakthrough Therapy Designation by the NMPA

SHANGHAI, March 2, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the Center for Drug Evaluation (CDE) ofChina's National Medical ...

2025-03-03 08:15 3060

Breakthrough! Exciting interim Phase II Data of LP-003 in CSU released by Longbio at AAAAI 2025

SAN DIEGO, March 2, 2025 /PRNewswire/ -- Longbio Pharma (Suzhou) Co., Ltd. (referred to as "Longbio"), a leading biotech company dedicated to developing innovative biologic treatments for allergy, respiratory, dermatology, hematology, ophthalmology, and other autoimmune and rare diseases, proudly...

2025-03-03 02:00 3198

EMSRUN Medical Strengthens Middle East Footprint with Innovative Emergency Care Solutions at IDEX & NAVDEX 2025

ABU DHABI, UAE, March 1, 2025 /PRNewswire/ -- EMSRUN Medical , a leading supplier for tactical, pre-hospital, and civilian emergency medical solutions, proudly showcased its groundbreaking emergency care technologies and enhanced its brand presence in theMiddle East at the I...

2025-03-01 20:06 4247

CARsgen's Allogeneic CD19/CD20 CAR-T Therapy Administers First Dose in a Patient with Autoimmune Disease

SHANGHAI, Feb. 27, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that KJ-C2219, an allogeneic CAR-T therapy targeting CD19/CD20, has a...

2025-02-28 08:15 3013

Akeso Announces First ADC Drug Clinical Trial, Marking a New Era for "IO 2.0 + ADC" Strategy

HONG KONG, Feb. 27, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) announced the first patient has been enrolled in the Phase I clinical trial of AK138 D1 for the treatment of advanced malignancies inAustralia. AK138D1, a self-developed and differentiated HER3-targeting ADC (antibody-drug conjugate)...

2025-02-27 16:58 2551

WuXi Biologics Again Passed GMP Inspection by Japan PMDA

WUXI, China, Feb. 26, 2025 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced that it has again passed the GMP inspection byJapan's Pharmaceuticals and Medical Devices Agency (PMDA) for it...

2025-02-27 12:30 2790

Fosun Pharma Received NMPA Approval for Wan Ti Le (Tenapanor Hydrochloride Tablets)

Bringing New Hope to Chinese Dialysis Patients with Hyperphosphatemia SHANGHAI, Feb. 26, 2025 /PRNewswire/ -- Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma; stock code: 600196.SH, 02196.HK) announced that its holding subsidiary, Shanghai Fosun Pharmaceutical Industrial Development...

2025-02-26 18:33 3129

HBM Alpha Therapeutics Enters Strategic Collaboration and License Agreement to Advance Novel Endocrine Therapies

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI , Feb. 25, 2025 /PRNewswire/ -- HBM Alpha Therapeutics (HBMAT), Inc., an innovative biotechnology company incubated by Harbour BioMed (HKEX: 02142), announced a strategic collaboration and license agreement with a business partner to advance ...

2025-02-26 08:03 2751

Kangpu Biopharmaceuticals Received IND Approval from NMPA for KPG-818 to Treat Relapsed/Refractory Multiple Myeloma

HEFEI, China, Feb. 25, 2025 /PRNewswire/ -- Kangpu Biopharmaceuticals, Ltd. ("Kangpu") today announced that the Company has received IND approval from the CDE (Center for Drug Evaluation) of China National Medical Products Administration (NMPA) for KPG-818 for the treatment of relapsed/refractory...

2025-02-25 21:00 2597

$Kangpu Biopharmaceuticals Received IND Approval from NMPA for KPG-818 to Treat Relapsed/Refractory Multiple Myeloma$

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